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EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14155-2:2003

Publication date:   Mar 25, 2005

General information

99.60 Withdrawal effective   Jul 15, 2009

CEN

CEN/TC 258 Clinical investigation of medical devices

European Norm

11.040.01   Medical equipment in general

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Scope

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN ISO 14155-2:2003
99.60 Withdrawal effective
Jul 15, 2009

REVISED BY

WITHDRAWN
EN ISO 14155-2:2009